Therapy with ibrutinib for patients with Chronic lymphocytic leukemia with subclonal TP53 aberrations
- Conditions
- Chronic Lymphocytic Leukemia (CLL)Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2024-514823-41-00
- Lead Sponsor
- Ospedale San Raffaele S.r.l.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
>=18 years old, Documented diagnosis of CLL according to International workshop on CLL (IwCLL) 2008 criteria, Previously untreated (steroid treatment previously administered to control autoimmune complications is allowed), Negative HBsAg and negative HBcAb or positive HBcAb and negative for HBV DNA by quantitative PCR, HCV antibody negative or, in case of HCV antibody positive, HCV RNA negative, Progressive disease requiring treatment according to IwCLL 2008 criteria, Cohort 2 only: Evidence of a small (<20%) subclone carrying TP53 deletion by FISH
Histologically documented transformation from CLL to aggressive lymphoma (Richter transformation), History of stroke or intracranial hemorrhage within 6 months prior to enrollment, Concomitant use of warfarin or other Vitamin K antagonists, Requires treatment with a strong cytochrome P450 (CYP) 3A inhibitor, Evidence of clonal TP53 mutations detected by Sanger sequencing and/or del17p in =20% of the nuclei by FISH
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method